IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER

Instructor: E.J Smith
Product ID: 700956
  • Duration: 60 Min

recorded version

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Training CD

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This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

The most important step in the PMA process is the IDE for your clinical trial(s). This presentation covers all of the steps one should take when beginning the IDE process for a PMA. Emphasis is placed on protocol.

Areas Covered in the seminar:

  • Getting Stated.
  • Meetings with FDA.
  • Sample Size Considerations.
  • Inclusion/Exclusion Criteria.
  • End Points.
  • Contraindication, Precautions, Cautions, Adverse Events.
  • Case Report Forms.
  • Administrative Plan.

Who will benefit:

This webinar is directed at any company that will have to perform a clinical trial to support their safety and effectiveness claims.

  • Sponsor
  • Regulatory Manager
  • Clinical Specialist
  • Venture Capitalist

Instructor Profile:

E.J. Smith, is a co-founder of Smith Associates, a FDA regulatory consulting firm that specializes in the preparation of 510(k), PMA and IDE submissions, device and cosmetic labeling, quality system audits and clinical trials. E.J. is the author of Hospital Consumables and Smith’s Reference and Illustrated Guide to Surgical Instruments and has 43 years of experience in medical marketing, executive positions and FDA regulatory affairs.

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria..Credit available for Live webinar Attendees only.

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Product Reviews Write review

This presentation was better than most I have attned. Comprehensive coverage in 1 hour with lots of "tidbits".
- Anonymous

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